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`RecentlyApproved Devices > Edwards SAPIEN Transcatheter Heart Valve (THV) P100041
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`Edwards SAPIEN Transcatheter Heart Valve
`(THV) P100041
`
`This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety
`and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the
`basis for FDA’s approval.
`
`Product Name: Edwards SAPIEN Transcatheter Heart Valve Model 9000TFX and accessories
`PMA Applicant: Edwards Lifesciences
`Address: Edwards Lifesciences LLC, One Edwards Way, Irvine, CA 9261
`Approval Date: November 2, 2011
`Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf10/p100041a.pdf (https://wayback.archive
`it.org/7993/20161023015438/http://www.accessdata.fda.gov/cdrh_docs/pdf10/p100041a.pdf)
`
`What is it? The Edwards SAPIEN Transcatheter Heart Valve (THV) is a heart valve that is made of cow tissue attached to a
`stainless steel mesh frame with a polyester wrap.
`
`How does it work? The device is inserted into the body by cutting a small opening in the artery carrying blood to the leg. The valve is
`placed on the end of a tubelike device called a balloon catheter, and is inserted into the opening in the leg. The catheter is pushed
`through the blood vessels until it reaches the damaged and/or diseased valve. The balloon on the end of the catheter is then blown up
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`6/21/2017
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`RecentlyApproved Devices > Edwards SAPIEN Transcatheter Heart Valve (THV) P100041
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`to expand the valve so it stays in place. Once the new valve is in place, it helps the blood flow properly by opening and closing like a
`door at the correct time to force the blood to flow in the correct direction.
`
`When is it used? The SAPIEN THV is used in patients whose aortic heart valve is damaged and/or diseased due to calcium build up
`and causes the valve to narrow (senile aortic valve stenosis) so blood is not able to flow efficiently. As the heart works harder to pump
`enough blood through the smaller opening, the heart eventually becomes weak. This can lead to symptoms and lifethreatening heart
`problems such as fainting, chest pain, heart failure, irregular heart rhythms (arrhythmias (https://wayback.archive
`it.org/7993/20161023015438/http://www.nlm.nih.gov/medlineplus/arrhythmia.html)), or cardiac arrest
`(https://wayback.archiveit.org/7993/20161023015438/http://www.nlm.nih.gov/medlineplus/cardiacarrest.html). Once
`symptoms of senile aortic valve stenosis occur, over half of the patients die within two years. The SAPIEN THV should only be used
`in patients who cannot undergo open heart surgery to have their valve replaced, as determined by a surgeon.
`
`What will it accomplish? Implantation of the SAPIEN THV can help restore normal blood flow in the heart in patients with senile
`aortic valve stenosis who need openheart surgery to replace the damaged and/or diseased valve, but for whom such a procedure is
`too risky. Patients who received this device had 3 times more strokes than those who did not get the device. They also had many
`more complications with the arteries leading to their legs.
`
`When should it not be used? The device and delivery system should not be used in patients who cannot tolerate bloodthinning
`medicines, or who have active infections near the valve or in the body.
`
`Additional information: Summary of Safety and Effectiveness and labeling (https://wayback.archive
`it.org/7993/20161023015438/http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=p100041) are
`available online.
`
`Other Resources:
`
`FDA News Release
`(/7993/20161023015438/http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm278348.htm)
`Society of Thoracic Surgeons Aortic Valve (https://wayback.archive
`it.org/7993/20161023015438/http://www.sts.org/patientinformation/valverepair/replacementsurgery/aorticvalve)
`(https://wayback.archive
`it.org/7993/20161023015438/http://www.fda.gov/AboutFDA/AboutThisWebsite/WebsitePolicies/Disclaimers/default.htm)
`
`More in RecentlyApproved Devices
`(/7993/20161023015438/http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/Recently
`ApprovedDevices/default.htm)
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`2015 Device Approvals
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`ApprovedDevices/ucm430692.htm)
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`2016 Device Approvals
`(/7993/20161023015438/http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/Recently
`ApprovedDevices/ucm494389.htm)
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